OccuLogix faces possible delay of RHEO launch, expands into AMD market

By Elaine Rigoli

Tampa, Fla., April 4 - OccuLogix, Inc. announced Tuesday that due to a possible delay of the U.S. commercial launch of its RHEO system, the company has accelerated its diversification plans, focusing on age-related eye diseases, such as age-related macular degeneration (AMD) and glaucoma.

On March 9, OccuLogix announced positive results from the modified per-protocol analysis of MIRA-1, the company's recently completed phase 3 clinical trial using its RHEO system to treat the dry form of AMD.

OccuLogix said it plans on meeting with the Food and Drug Administration in the second quarter to discuss what impact the MIRA-1 study results and the modified per-protocol analysis will have on its application to market its system in the United States.

Without predicting what the FDA will require for approval, OccuLogix said it expects further study will be required because the modified per-protocol population comprised 115 complete data sets while the company had been required to obtain a minimum of 150 complete data sets.

OccuLogix said it has started its expansion into the glaucoma space by signing a letter of intent to acquire SOLX, Inc., a company that has developed the DeepLight Glaucoma Treatment System.

Both of the components of the DeepLight system have received CE Mark approval from the European Agency for the Evaluation of Medicinal Products and are currently the subject of two randomized, multi-center studies in the United States, the release said.

SOLX expects to obtain 510(k) approval to market both components of the DeepLight system in the United States before the end of 2007.

While financial terms of the transaction were not disclosed, OccuLogix will provide SOLX with a $2 million bridge loan and has advised that it expects substantially all of the purchase price of SOLX to be paid in OccuLogix stock.

OccuLogix is a Toronto, Ont.-based health care company that develops evidenced-based medical therapies.

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